Reports To: Senior Vice President and Chief Medical Officer
Position Type: Contract position
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.
The Medical Writer will support efforts in the strategy, planning, execution and reporting of Tocagen’s clinical trials. The primary responsibilities of this position is executing on medical writing deliverables including medical disclosures (abstracts, posters, slide presentations, manuscripts) and clinical, preclinical, non-clinical toxicology, and CMC documents for global regulatory submissions, clinical protocols and study reports, investigator brochures, investigational plans, clinical trial results postings, and other key clinical and regulatory documents.
These types of clinical and regulatory documents can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (i.e., integrated summaries of safety and efficacy, product labeling, summaries and overviews of nonclinical and clinical information). Knowledge of drug development processes and FDA/EMEA guidelines required.
Duties and Responsibilities Include But Are Not Limited To:
- Responsible for planning, preparation, writing, reviewing, editing, formatting, and finalizing medical disclosure and regulatory documents (Clinical, Pre-clinical, Non-clinical toxicology and CMC programs) and external publications for marketed products and compounds in development.
- Documents include, but are not limited to, medical disclosures (abstracts, posters, slide presentations, manuscripts), global submission documents (NDAs, MAAs), clinical protocols, clinical study reports, investigator brochures, annual updates to regulatory submissions, other regulatory submission documents (INDs, BLAs, Briefing documents, ad-hoc requests from regulatory agencies, etc.) for internal or external use.
- Coordinate writing activities for project teams, including timelines and document review/revision responsibilities; cross-functional collaboration with biostatistics, clinical operations, project management, medical affairs, pharmacovigilance, regulatory, quality assurance, manufacturing, and commercial.
- Conduct literature searches, interpret scientific literature, and evaluate various technologies, prepare analyses, interpret, and summarize data, and evaluate study data from tables and listings.
- Review and interpret records or reports related to Tocagen projects, such as non-clinical data, and/or draft tables, figures and listings, to ensure that they provide the appropriate information or data for creation of clinical documents.
- Perform peer review of various clinical or regulatory documents and publications. Preparation and finalization of clinical documents including responses to questions from peer-reviewers and assuring adherence to agreed timelines.
- Participate in group initiatives in relation to document standards, continuing template development, cross-functional processes and other aspects of document management (in collaboration with publishing group).
- Participate in medical writing process development and process improvement initiatives.
- Ensure compliance, remain informed on regulations and developments in medical writing, and maintain knowledge of product areas, current trends, and current literature.
- Keep abreast of current external guidance and expectations relevant to deliverables (e.g. publications development/submission) and contribute to the discussion of communications/ publications/training strategies.
- Contribute towards development opportunities to promote scientific collaborations and partnerships as required.
- Contribute to the oversight and review of clinical data.
- Contribute to key cross-functional and clinical meetings (e.g., investigator meetings, ad hoc meetings, scientific focus or steering committee meetings).
- Identify potential collaborators and investigators.
- Perform other duties as required.
Desired Knowledge and Abilities:
- Excellent writing skills coupled with comprehensive knowledge of GCPs, ICH, FDA, EMEA regulations and guidelines, and other international regulatory requirements.
- In-depth knowledge of the drug development process.
- Demonstrated record of overseeing the successful planning and implementation of medical disclosures.
- Ability to interpret and present scientific and clinical trial data and understand statistical methods and analysis plans.
- Demonstrated record of contributing to the successful planning and implementation of a publication plan; able to manage key opinion leaders as external authors.
- Proven ability to facilitate issue/comment resolution as it relates to finalization of medical writing deliverables.
- Appropriate computer software experience (including but not limited to Prism, MS Word, Excel, PowerPoint), in particular, document management software; experience with electronic filings.
- Manage multiple and varied programs with competing and aggressive time lines, prioritize activities, and work independently.
- Able to work in a quickly changing, not fully structured internal and external environment.
- Strong interpersonal and communication skills; proactive approach.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies.
Education & Experience:
- Bachelor’s degree in life sciences with 4-5 years or more direct biotechnology or pharmaceutical industry experience as a medical writer, or advanced scientific degree in life sciences (MS or PhD) with 2-3 years or more direct biotechnology or pharmaceutical industry experience as a medical writer.
- Prior industry experience in contributing to the preparation of non-clinical and clinical protocols, study reports, IND, IB, BLA, NDA documents.